Integrity INT30018UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994798503), received between Mar 10, 2017 and Jan 7, 2022 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2022Migration or Expulsion of Device; Device Dislodged or Dislocated; Material Deformation; Migration or Expulsion of Device; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE AN INTEGRITY RX CORONARY BARE METAL STENT TO TREAT THE LEFT VERTEBRAL ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT THE INTEGRITY BARE METAL STENT WAS PLACED IN A GUIDE SHEATH BUT THE GUIDE SHEATH BECAME DISLODGED, THEREFORE THE STENT WAS REMOVED TO REPOSITION IN THE GUIDE SHEATH. WHEN AN ATTEMPT WAS MADE TO USE A BALLOON TO DEPLOY THE STENT, IT WAS NOTICED THAT THE STENT HAD FALLEN OFF THE BALLOON AND INJECTION SHOWED THAT THE STENT HAD MIGRATED AND WAS FLOATING IN THE LEFT VERTEBRAL ARTERY UNEXPANDED. THE STENT WAS RETRIEVED AND REMOVED POSSIBLY USING A SNARE AND THE PROCEDURE WAS CONTINUED. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13190188 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A REVASCULARIZATION PROCEDURE ONE RESOLUTE INTEGRITY BMS WAS IMPLANTED IN THE RCA. APPROXIMATELY 9 MONTHS LATER THE PATIENT WAS TREATED FOR SEVERELY CALCIFIED RCA AND INTENT RESTENOSIS OF THE MID RCA, DURING THE PROCEDURE PLAQUE PROLAPSE WAS NOTED AND THE PATIENT WAS TREATED WITH TWO MEDTRONIC STENTS IN THE RCA. THE PATIENT WAS STABLE AND DISCHARGED HOME.

  Patient problems: Injury; Stenosis

  MAUDE report 10656393 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A REVASCULARIZATION PROCEDURE ONE RESOLUTE INTEGRITY BMS AS IMPLANTED IN THE RCA. APPROXIMATELY 6.5 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM WORSENING CORONARY ARTERY DISEASE AND WAS TREATED WITH MEDICATION AND REVASCULARIZATION OF THE RCA.

  Patient problems: Injury; Stenosis

  MAUDE report 10656267 ↗
• InjuryMay 24, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED TO USE A INTEGRITY BARE-METAL STENT TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT MAIN (LM) CORONARY ARTERY, CIRCUMFLEX (CX) ARTERY AND THE OBTUSE MARGINAL (OM). THE LESION WAS REPORTED TO BE SEVERELY TORTUOUS AND SEVERELY CALCIFIED WITH 75% STENOSIS. IT WAS REPORTED THAT THERE WAS A SHARP 90 DEGREE BEND FROM LEFT MAIN INTO THE CIRCUMFLEX. NO DAMAGE WAS NOTED TO PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICES FROM PACKAGING. THE DEVICES WERE INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS ALSO PERFORMED WITH NO ISSUES. THE 3.0X 30 INTEGRITY WAS ATTEMPTED FIRST. THE LESION WAS NOT PRE-DILATED AND THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT BUT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT WAS REPORTED THAT THE STENT DID NOT CROSS THE LESION AND AFTER IT WAS REMOVED FROM THE BODY A STENT STRUT ON THE PROXIMAL END WAS NOTED TO BE BENT OUT. A 3.0 X 18 INTEGRITY WAS THEN USED IN CASE A SHORTER STENT WOULD BE ABLE TO CROSS. NO DIFFICULTIES WERE NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT BUT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6586895 ↗
• InjuryMar 14, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN WAS ATTEMPTING TO USE AN INTEGRITY STENT TO TREAT A DISTAL SAPHENOUS VEIN GRAFT. IT WAS REPORTED THAT NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING. NO ISSUES WERE ENCOUNTERED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STENT DISLODGED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS REMOVED WITH A SNARE SUCCESSFULLY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6401975 ↗
• MalfunctionMar 10, 2017Material Deformation; Material Deformation

  THE PHYSICIAN WAS ATTEMPTING TO USE AN INTEGRITY STENT TO TREAT A SEVERELY TORTUOUS MID LAD LESION. IT WAS REPORTED THAT NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING. NO ISSUES WERE ENCOUNTERED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING DELIVERY AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED DURING POSITIONING AND THEN RETRACTING. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6394284 ↗